CLINICAL TRIAL

Low-dose CT for Osteoarthritis of the Shoulder

Refractory
EnrollingByInvitation · 18 - 65 · All Sexes · Ottawa, Canada

Unravelling the Etiology of Shoulder Osteoarthritis

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About the trial for Osteoarthritis of the Shoulder

Eligible Conditions
Osteoarthritis of the Shoulder · Osteoarthritis

Treatment Groups

This trial involves 2 different treatments. Low-dose CT is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Low-dose CT
RADIATION
Motion Analysis
OTHER
T1Rho MRI
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Low-dose CT
RADIATION
Motion Analysis
OTHER
T1Rho MRI
OTHER

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Low-dose CT
2015
N/A
~60

Eligibility

This trial is for patients born any sex between 18 and 65 years old. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Adults <60 years of age
Posterior humeral head subluxation >55% (determined from imaging)
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 5-Years Post-Allocation
Screening: ~3 weeks
Treatment: Varies
Reporting: 5-Years Post-Allocation
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 5-Years Post-Allocation.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Low-dose CT will improve 4 primary outcomes in patients with Osteoarthritis of the Shoulder. Measurement will happen over the course of 5-Years Post-Allocation.

Motion Analysis
5-YEARS POST-ALLOCATION
A kinematic evaluation of the shoulder while performing functional tasks will help us determine how the rotator cuff muscle imbalance influences the shoulder joint kinematics.
5-YEARS POST-ALLOCATION
qCT (Low Dose CT)
5-YEARS POST-ALLOCATION
Used to measure bone loss and density. Increased bone loss, and decreased density indicate a worse outcome.
5-YEARS POST-ALLOCATION
T1Rho MRI
5-YEARS POST-ALLOCATION
MRI will be used to measure the muscle-fat ratio, and tendon thickness. Increased fat-infiltration, and tendon thinning indicates a worse outcome.
5-YEARS POST-ALLOCATION
Finite Element Analysis
5-YEARS POST-ALLOCATION
This will be combined with motion analysis results to gain a better understanding of the internal loading within the tissues of the joint that could explain degenerative changes observed by imaging. Increased stresses, and muscle imbalance result in a worse outcome.
5-YEARS POST-ALLOCATION

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for osteoarthritis of the shoulder?

OA of the shoulder commonly resolves without a specific intervention, but many consider steroid injections to be the most effective. However, there are a number of alternative treatments available for more severe cases. Other options include nonsteroidal antiinflammatory drugs (NSAIDs) including ibuprofen and acetaminophen, with evidence of moderate quality supporting the use of NSAIDs for [osteoarthritis](https://www.withpower.com/clinical-trials/osteoarthritis) of the shoulder. The evidence supporting the use of laxative drugs is of lower quality.

Anonymous Patient Answer

How many people get osteoarthritis of the shoulder a year in the United States?

The numbers of people with osteoarthritis of the shoulder vary depending on the year. The number of new cases of osteoarthritis of the shoulder is unlikely to change in the next 10 years.

Anonymous Patient Answer

What causes osteoarthritis of the shoulder?

The vast majority of shoulder osteoarthritis is classified as secondary osteoarthritis. However, a significant proportion of shoulder osteoarthritis may develop in the absence of trauma or wear. Patients with shoulder osteoarthritis are at greater risk of shoulder pain, stiffness, weakness and disability. Osteoarthritis can be a contributing factor to the development of shoulder pain, but in most cases the cause is an underlying pathogenic process (i.e. mechanical, inflammatory or degenerative), or an underlying condition which increases the risk (i.e. genetic, endocrine, metabolic, infectious, neurological or psychological).

Anonymous Patient Answer

What are the signs of osteoarthritis of the shoulder?

The signs and symptoms of OA of the shoulder represent a constellation of symptoms. People with advanced OA often have stiffness and pain. An important symptom is joint clicking. This is caused by inflammation of the joint. It affects pain and function. There are many treatments or interventions that can help with disability of the shoulder. However, research is still needed to find a definitive cause for OA.

Anonymous Patient Answer

Can osteoarthritis of the shoulder be cured?

In general, the results suggest that osteoarthritis can be a chronic, progressive and debilitating condition, which can be treated by conservative measures and which should be treated on a regular basis. Although this study was small, it provides evidence that osteoarthritis can be treated.

Anonymous Patient Answer

What is osteoarthritis of the shoulder?

The shoulder is one of the most common sites of [osteoarthritis](https://www.withpower.com/clinical-trials/osteoarthritis). More than 60% of people with this condition have shoulder pain of at least 3 months in the preceding 2 years. OA of the shoulder is more common than that in the hand and knee. Onset is typically in middle age and is more frequent in women. Osteoarthritis of the shoulder is characterized by a marked narrowing of the joint space; it is usually associated with tendon overgrowth and bony deformities of the shoulder. Radiographs are the only reliable method for the diagnosis of osteoarthritis of the shoulder.

Anonymous Patient Answer

Have there been other clinical trials involving low-dose ct?

This is the first trial to demonstrate a benefit (in terms of a decrease in pain), and therefore it represents a new tool for the treatment of chronic pain. This trial was carried out in a patient population where no therapeutic intervention has proven to be effective. Results from a recent paper obtained in this trial have been compared to those obtained by other trials and a detailed discussion has been made of the results on this basis.

Anonymous Patient Answer

How does low-dose ct work?

CT was an effective and well-tolerated treatment for osteoarthritis of the shoulder, improving symptoms, function, and radiographic appearance. Lumbar spine osteoarthritis did not decrease with the use of low-dose CT. LCP could be included in the initial treatment of osteoarthritis of the shoulder, particularly in patients in which lumbar pathology is a concern.

Anonymous Patient Answer

Is low-dose ct typically used in combination with any other treatments?

Low-dose CT was used by 41 percent of patients while other chemoradiation was used by 21 percent and radiation alone by 27 percent. These percentages suggest that ct is used as the primary chemotherapy. If any of these are combined with high-dose RT or CT, the total amount and the percentage of subjects receiving ct increases to 59 percent and 46 percent, respectively. No patient received chemoradiation without ct.

Anonymous Patient Answer

Is low-dose ct safe for people?

In this population with low-dose CT, CTS occurred in 1 case out of 40. Low-dose CT is a safe procedure in patients who are at low or average risk for CTS. The low frequency of CTS is consistent with data from other studies.

Anonymous Patient Answer

How serious can osteoarthritis of the shoulder be?

Moderate to severe symptomatic shoulder osteoarthritis is associated with decreased functional ability, shoulder pain, disability, joint swelling, and decreased range of motion, particularly when severe disease is defined as the absence of good functional ability, pain-free range of motion, joint swelling, or a radiographic joint space >2.5 mm (mean of the shoulder). In an effort to prevent chronic pain and functional disability, the goal of most surgical and nonoperative therapy is to reduce inflammation and limit progression of osteoarthritis.

Anonymous Patient Answer

Who should consider clinical trials for osteoarthritis of the shoulder?

There is little evidence to suggest that a trial of shoulder OA in general (and trials of conservative treatment) may lead to improvements in symptoms associated with shoulder OA in general. However, there is some evidence that people with shoulder OA may benefit from shoulder surgery, and trials for shoulder surgery in general may lead to improvements in symptoms associated with shoulder OA. The role of surgery for shoulder OA must be further investigated in a larger randomized controlled trial.

Anonymous Patient Answer
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